Ferumoxytol in Improving MR Imaging in Patients With High-Grade Brain Tumors or Cerebral Metastases
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|ClinicalTrials.gov Identifier: NCT00103038|
Recruitment Status : Unknown
Verified June 2018 by Edward Neuwelt, OHSU Knight Cancer Institute.
Recruitment status was: Active, not recruiting
First Posted : February 8, 2005
Last Update Posted : July 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Central Nervous System Lymphoma Malignant Glioma Metastatic Malignant Neoplasm in the Brain||Procedure: 3 Tesla Magnetic Resonance Imaging Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging Drug: Ferumoxytol Drug: Gadolinium Procedure: MRI-Based Angiogram||Not Applicable|
I. Investigate the utility of ferumoxytol and gadolinium-based contrast agent (GBCA) for improved imaging biomarkers of malignant brain tumors in a single imaging session by comparing dynamic susceptibility contrast (DSC) determined relative cerebral blood volume (rCBV) and dynamic contrast enhancement (DCE) determined vascular permeability (derived transfer coefficient [Ktrans]).
I. Compare and evaluate magnetic resonance angiography (MRA) with ferumoxytol between different time points.
II. Assess number and size of tumors imaged. III. Assess tumor vascularity. IV. Assess histology and electron microscopy (EM) on tissue samples. V. Assess differences in subjects with prior therapy versus (vs.) no prior therapy (radiation and/or chemotherapy).
VI. Assess the long term imaging characteristics of different tumors using DSC and DCE.
Patients receive ferumoxytol non-stoichiometric magnetite intravenously (IV) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients also undergo MRI without contrast at baseline and on day 2. Imaging with ferumoxytol, GBCA, and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years.
After completion of study, patients are followed up at approximately 4-6 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||155 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NCI-Sponsored Multi-Disciplinary Study for MR Imaging of Intravenous Superparamagnetic Crystalline Particle Ferumoxytol in Primary High-Grade Brain Tumors and/or Cerebral Metastases|
|Study Start Date :||February 2004|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||April 2020|
Experimental: Diagnostic (ferumoxytol, gadolinium, DCE-MRI, DSC-MRI)
Patients receive ferumoxytol non-stoichiometric magnetite IV beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients also undergo MRI without contrast at baseline and on day 2. Imaging with ferumoxytol, GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years.
Procedure: 3 Tesla Magnetic Resonance Imaging
Undergo 3T MRI
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo 3T DCE-MRI
Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
Undergo 3T DSC-MRI
Other Name: Dynamic Susceptibility Contrast-Enhanced MRI
Other Name: Gd
Procedure: MRI-Based Angiogram
- Ktrans [ Time Frame: Up to 5 years ]Appropriate descriptive statistics (mean, standard deviation, minimum, median, and maximum) will be estimated for the imaging parameters Ktrans. Frequency distributions of each parameter will also be described to assess normality. Pearson's correlation coefficients will be estimated to describe potential relationships among these various measures.
- rCBV [ Time Frame: Up to 5 years ]Appropriate descriptive statistics (mean, standard deviation, minimum, median, and maximum) will be estimated for the imaging parameters rCBV. Frequency distributions of each parameter will also be described to assess normality. Pearson's correlation coefficients will be estimated to describe potential relationships among these various measures.
- Overall survival [ Time Frame: Up to 4-6 weeks after completion of study ]To evaluate the value of rCBV for improved clinical management, overall survival times will be assessed using Kaplan-Meier product limit estimates and will compare patients with rCBV =< 1.75 and those with rCBV > 1.75 using the log-rank test. In addition, the Cox proportional hazard model will be used to estimate hazard ratios while adjusting for potential confounding variables if necessary. This analysis will be conducted for subjects of high-grade brain tumors, and other subjects separately.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00103038
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Edward Neuwelt||OHSU Knight Cancer Institute|